Media Quality Control

media Quality Control

Media Lot Acceptance Testing with maximal Supply Chain Control In Just 3 Days

The Valita™QC assay applies ChemStress Fingerprinting for quality control testing of media batches. In trials, we have demonstrated that the Valita™QC can be used to detect poor quality media batches in comparison with an accepted reference lot. Valita™QC works on the basis that a cell clone and media combination has a highly unique stress response fingerprint, and any change in the fingerprint is due to changes in media formulation.

Media lot testing is currently performed using a range of tests including pH, standard cell culture growth & productivity estimations with a reference host cell line, etc, yet they do not have the ability to detect significant changes in cell culture media. Valita™QC is positioned as a routine 'Media Lot Acceptance' test, which can carry out media lot testing in 3 days, by detecting changes in media through changes in a cell lines stress response fingerprint.

Control

Ability to confidently identify the impact of variances in cell media formulations

Ease of Use

Reduction in 'failed production runs' due to cell media inconsistencies

Faster Results

Detailed phenotypic analysis within 3 days

Technology Platform: ChemStress Fingerprinting

The ChemStress plate simulates the biological and environmental stresses a cell clone encounters in a bioreactor. Each of the wells of the ChemStress 96-well plate are pre-coated with multiple small molecule chemicals, which re-create the environmental and biological stresses of a bioreactor. Each chemical has been carefully selected to challenge a particular aspect of a cell clones biochemistry. Some of these challenges include: Nutrient Starvation; Oxidative Stress; pH, Osmolarity and Toxicity. For example, Brefeldin A inhibits protein transport and is a lactone antibiotic.

How To Generate A ChemStress Fingerprint

An individual cell clone is grown in the ChemStress plate for 3 days. After exposure to the chemical stressors, clonal growth and product titre are measured in response to each of the chemical stressors. This is read on a plate reader and analysed using the Valitacell software 'ValitaAPP'. ValitaAPP performs the analysis of a cell clones growth and titre profile using product-specific algorithms. This makes up a clones ChemStresss Fingerprint, and this fingerprint is unique to an individual cell clone or a media batch.

1) An individual cell clone is grown in the ChemStress plate for 3 days and exposed to the numerous small molecule chemicals 2) A clones growth and productivity are measured on a plate reader 3) ValitaAPP software applies product-specific algorithms to analyse the growth and titre data and a ChemStress fingerprint is generated.